Following is the text of a testimony presented by Berkley Bedell, a former U.S. Congressman from the state of Iowa before a U.S. Senate committee investigating alternative medicine.
My name is Berkley Bedel!. I am the founder of Berkley and Company, a major fishing tackle manufacturing company which I started in High School with $50 saved from my newspaper route. I was the nation’s first small business person of the year, and served in the United States Congress from 1975 until 1987. I fully realize that this background does not qualify me as one of the scientific experts on health. I happen to think that is good. I start with no pre-conceived beliefs on health care that may need to be changed.
I serve on the ad-hoc advisory committee to this new Office of Alternative Medicine. I am knowledgeable about some of the problems it faces in conducting the “investigations and validations” called for in this legislation.
I left Congress because I came down with Lyme disease which I contracted while fishing at Quantico Marine Base, and which conventional treatment failed to relieve. After 3 series of heavy doses of antibiotics infused into my veins over a period of 2 years, I finally turned to an unconventional treatment. My symptoms disappeared and today I am clearly free of Lyme disease.
Let me tell you about that treatment. There is a company in our own state of Iowa, Mr. Chairman, that produces a product for livestock by injecting killed germs into the udder of a cow prior to the time the cow has a calf. When the cow has the calf, they then take the first milk that the cow gives, which is called colostrum, and process it into whey so that it will keep.
The theory is that the cow will communicate the disease to the unborn calf, and will develop the antibodies, or whatever, in the colostrum to protect the newly-born calf from that disease.
After I took a teaspoon of this whey every 1 1/2 hours for a few weeks, my symptoms of Lyme disappeared, and I no longer suffer from that disease. Because of the publicity of my case, I get frequent phone calls from desperate people who have been unable to get relief from Lyme with conventional treatment. It breaks my heart that I cannot tell them about my treatment, because no one has been willing to spend the millions and millions of dollars necessary to get FDA approval to market this special whey. lean tell you that it cured what appeared to be arthritis in my knee in 15 minutes.
Recently the company which produced the whey which I believe cured my Lyme disease made a homeopathic preparation from this whey, as homeopathics are exempted from some FDA regulations by law. I have talked to a doctor in Wisconsin who was using this material. He claims 80-90% success in treating patients like me for whom conventional treatments have not been effective. He has now been advised by the Iowa producer that the material will no longer be available because the producer is afraid of the FDA.
Mr. Chairman, I wish you could hear the heartbreaking stories people relate to me about their disease. Just this week I had a call from a lady in Kansas City, Missouri, whose life has been literally ruined by Lyme. Her treatments have cost about $100,000, and now her insurance has been cancelled. She has no money – and the low cost treatment I believe cured me has been cancelled because of FDA policies.
Recently, the producer of this whey requested permission from the FDA to test this whey in the treatment of Herpes. I have furnished the committee with a copy of part of the FDA reply. I am informed that these ridiculous requirements that the company run a whole series of tests which could take up to 5 years to find out why it works absolutely kills the project.
Mr. Chairman, this is whey from milk with absolutely nothing added – and we cannot even see if it is effective in curing diseases without going through a whole series of FDA requirements. Unfortunately, Little Miss Muffet is not available to testify that the curds and whey which she was eating are safe.
At a recent meeting which I attended, a practitioner asked the FDA representative if she could test the effectiveness of garlic in treating disease without going through the lengthy FDA approval process. The answer was No!!
I relate this all to you to illustrate how current FDA policies prevent the testing and use of nontoxic alternative treatments. I am sure that most members of Congress are not aware of this situation. In my opinion, to say that current FDA policies are a disaster to health care in America is a masterpiece of understatement.
I have included with my material a copy of a study that was done by a doctor at Tufts University. You will note on page 125 that the total cost per marketed drug for development and FDA approval was $230 million. You will also note on this page that the cost of animal studies and phase 1,2, and
3 trials required to get FDA approval to market the drug average $75.2 million. Mr. Chairman, people could argue about whether the average cost of getting FDA approval to market a medicine is 25, 75, or 125 million dollars. It matters not. The fact is that current FDA policies almost guarantee two things.
First, under current policies the chances of getting low cost medicines into the system is practically zero. No one is going to spend millions of dollars to get permission to market a product unless they can charge a high enough price for it to at least get their money back.
Secondly, this policy gives exclusive rights to the big pharmaceutical companies or other large corporations. Small researchers, practitioners and scientists do not have the money needed to go through the FDA approval process. All through history most creativity has come from researchers, scientists, and others working in small operations, not from giant corporations. And in medicine, current FDA regulations are most effective in shutting them out.
One of the indications of the interest in this field of alternative medicine is the large number of requests you have had from those who wished to testify at this hearing. You may want to have another hearing at a future date to further explore this matter.
One of the practitioners which I recommended be allowed to testify, but which time would not permit was a practitioner from Georgia who has had success in treating children with learning disabilities with amino acids. Amino acids are a comparatively safe inexpensive treatment. They have been available over the counter for years. I had hoped that she could come and testify with one of the learning disabled children who had been able to advance to the regular classroom because of this inexpensive treatment.
Mr. Chairman, last week the FDA issued some proposed new rules which would require anyone selling herbs or amino acids to first prove to the FDA’s satisfaction that they were safe. Unless there is a complete change in FDA’s policies this will result in the removal of all herbs and amino acids from the marketplace. No one is going to spend millions of dollars for approval to market a product that everyone else could then also market. If this is an effective treatment for large numbers of children with learning disabilities, such treatment will no longer be able to be pursued, and those children that could be helped will be sentenced to continued placement in the learning disabled class.
Of course, someone might succeed in making a different amino acid, or amino acid derivative on which a patent could be obtained; spend the millions of dollars necessary for FDA approval and sell it through prescription for many times current prices. Is that what we really want as we address the cost of health care?
Mr. Chairman, when I was in Congress, I had no idea of the situation that exists in health care in our country. In medicine we have a closed shop that is not open to anything new. For cancer only those who use conventional medicine are allowed to practice. Conventional cancer treatment is surgery, radiation and chemotherapy. Anyone doing almost anything else is labeled a “quack.”
The FDA’s job is to protect the people from harmful and ineffective drugs. The safest way for a bureaucrat to do that is to set up procedures that make it almost impossible for anything new to get into the market. They not only do that. The way the FDA goes after some alternative practitioners is unbelievable.
In some states the way the AMA and state medical boards go after anyone using something other than conventional therapy is a disgrace.
And the National Institutes of Health (NIH) and National Cancer Institute (NCI) procedures for investigating a new medicine are so costly and time-consuming as to make the change of an alternative therapy being fairly evaluated little better than zero.
That wouldn’t be so bad if current treatments were more effective. A recent study by a well respected European scientist found that the average life expectancy of people with advanced epithelial cancer was exactly the same for people who had no treatment, as compared to those given chemotherapy. Epithelial cancers are solid tumor cancers. These cancers make up 80% of cancer deaths.
In my opinion this committee took one of the most important actions in the history of health care when you established this office with a mandate to “investigate and validate” these alternative treatments. At this time, I see it as the only hope for getting lower cost, more effective treatments a hearing.
It may not be as scientific as some would like, but it is a comparatively simple matter to set up a protocol where patients will be checked by an outside clinic or laboratory to confirm the diagnosis before treatment, and then have the same patients checked by the same clinic or laboratory after treatment to see if the treatment was effective. Since the treatment is performed by the practitioner on regular patients, it involves very little government cost. It is called “outcomes research,” and it is what after 1 1/2 years this office seems to be finally starting to institute.
Further scientific confirmation may be advisable if such checks confirm effectiveness of a treatment. But for most seriously ill persons, their main concern about a treatment is whether it has been shown to be effective. And there are many who need it now – not in 5 or 10 years.
Mr. Chairman, the reality is that NCI neither believes in alternative treatments or these low cost outcomes evaluations. They get millions of dollars for in-house research, and to set up very expensive protocols for investigations. I am advised that they have only held 3 complete investigations of alternative treatments in all of their history. Until this office has a director and staff that is willing to function as an independent office within NIH, I see little hope of it fulfilling its legislative mandate.
Mr. Chairman, it is time for some straight talk. There are some powerful forces in our society that are doing quite well with things as they are. The pharmaceutical industry and the AMA have a monopoly on the treatment of cancer and most degenerative diseases. They are both doing quite well financially. How could one expect them to welcome change that might challenge their monopoly?
The FDA has unbelievable powers in regulating and controlling the health treatments of our country. And the NIH and NCI get large amounts of money to research medical treatments.
If this office were to confirm some low cost effective treatments that could be administered by most any practitioner, it would be a tremendous thing for our people. But it would not exactly be a bonanza for the pharmaceutical companies, AMA, FDA, and NCI.
These people are not bad people. But they have learned how the American system works, and one goal of any organization is to survive and to thrive.
There are powerful forces which this office (OAM) may well threaten if it can get its act together. The office, as you know, has been in operation for 1 1/2 years without completing a single investigation of these alternative treatments. Some of us on the ad-hoc advisory committee have been pushing with all our might to get this office to add the necessary staff, and to start procedures to “investigate and validate” some of these treatments. We have been like pygmies trying to get an elephant to go where it didn’t want to go.
It is also true that some of these forces have in the past used all sorts of means to try to destroy the credibility of those who try to change the system. Mr. Chairman, you and I have already been branded as misled or misinformed by those who see anything out of mainstream as “quackery.”
I do not know for sure whether any of these treatments really hold the key to successful treatments of these serious diseases or not. But I have seen too many tragic deaths from cancer, and too many people suffer from diseases where relief cannot be obtained from conventional medicine to shrink from trying with all my power to see that every possible treatment for which effectiveness is indicated is fully investigated.
I hope you, Mr. Chairman, and the rest of this committee will not shrink from this task, no matter how great the obstacles and opposition. I pledge my continued help.
I have learned this at least by my experiment: that if one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with a success unexpected in common hours.– Henry David Thoreau (1817-1862)